Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 204-557-2 | CAS number: 122-60-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Toxicity to reproduction
Administrative data
- Endpoint:
- two-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Scientific publication with restrictions compared to Guideline Study (limited documentation)
Data source
Reference
- Reference Type:
- publication
- Title:
- The inhalation toxicity of phenylglycidyl ether: Reproduction, mutagenic, teratogenic, and cytogenetic studies
- Author:
- James B. Terrill1, K.P. Lee, Rudolf Culik, Gerald L. Kennedy Jr.
- Year:
- 1 982
- Bibliographic source:
- Toxicology and Applied Pharmacology, Volume 64, Issue 2, 30 June 1982, Pages 204-212
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)
- Principles of method if other than guideline:
- Male rats were exposed to either 0, 1, 5, or 12 ppm, 6 hours/day on 19 consecutive days.
These rats were mated with untreated females and the pups were examined for abnormalities. Litters were mated among each other and the next generation was examined for abnormalities. - GLP compliance:
- no
Test material
- Reference substance name:
- Automatically generated during migration to IUCLID 6, no data available
- IUPAC Name:
- Automatically generated during migration to IUCLID 6, no data available
- Details on test material:
- Name in the report: propane, 1,2-epoxy-3-phenoxy
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Source: Charles River
- Age at study initiation: 10 weeks
- Weight at study initiation: Males: ca. 260 g (females not reported)
- Diet (ad libitum): Purina rat chow
- Water (ad libitum)
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- not specified
- Details on exposure:
- Chamber atmospheres were generated by syringe driving the liquid EPP into a heated (310°C) tube. The tube was housed in an oven and constructed in such a way that the nitrogen stream (10 liters/minute) which swept the vapors through the tube was the same temperature as the delivery tube. The exit port of the tube was connected to the top of a 4.5 m3 exposure chamber. Room air at 1,500 liters/minute was also drawn into the chamber at this point.
- Details on mating procedure:
- - M/F ratio per cage: 1/3
- Length of cohabitation: 5 days
- Proof of pregnancy: no data
- After successful mating each pregnant female was caged individually - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Atmospheric samples were collected hourly in a midget impinger that contained 15 cc of 0:1 N NaOH in a 50:50 ethanol-water mixture. Analysis was performed by U.V. spectrophotometry at 270 nanometers.
- Duration of treatment / exposure:
- 6h/day on 19 consecutive days (F0 males only)
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 1, 5, 12 ppm
Basis:
analytical conc.
- No. of animals per sex per dose:
- 8
- Control animals:
- yes, sham-exposed
- Details on study design:
- - Other:
- potential pregnancies were either terminated on the 18th day of gestation for examination of uterine contents or continued through parturition
- determination was dependent upon the number of litters sired per male:
-if three dams were impregnated, two were allowed to deliver and one pregnancy was terminated on the 18th day
-if two dams became pregnant, one was allowed to deliver, and one pregnancy was terminated
-if one litter was sired, it continued through to parturition
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: No data
- Time schedule:
BODY WEIGHT: No data
- Time schedule for examinations:
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
- Time schedule for examinations:
OTHER: - Oestrous cyclicity (parental animals):
- No data
- Sperm parameters (parental animals):
- Parameters examined in [all/P/F1/F2] male parental generations: testis weight, epididymis weight
- Litter observations:
- STANDARDISATION OF LITTERS
- Performed @ birth: yes
- If yes, maximum of 8 pups/litter ; excess pups were randomly killed and discarded.
PARAMETERS EXAMINED
The following parameters were examined in [F1 / F2] offspring:
[number and sex of pups, stillbirths, live births, weight gain, physical abnormalities]
GROSS EXAMINATION OF DEAD PUPS:
[no] - Postmortem examinations (parental animals):
- SACRIFICE
Male animals (All surviving animals):
- F0 male animals were sacrificed following completion of the F0 mating trails
- 8 males of each week and group not employed during the F1 mating trials (12 weeks post weaning) and F1 parental males
- any animal appearing abnormal
Maternal animals (All surviving animals):
- each F0 female animal failing to conceive and each failing to deliver by the 23rd day of gestation
- 8 females of each week and group not employed during the F1 mating trials (12 weeks post weaning) and F1 parental females
- any animal appearing abnormal
GROSS NECROPSY
Yes
HISTOPATHOLOGY:
yes: reproductive organs of all the above mentioned animals (in addition, any tissue or organ noted abnormal during gross pathologic examination - Postmortem examinations (offspring):
- SACRIFICE
- The F1 offspring not selected as parental animals were sacrificed at weaning and all F2 offspring were sacrificed 2 weeks post-weaning.
The pups were examined for physical abnormalities and developmental/behavioral anomalies at birth, at weaning and 2 weeks post-weaning prior to their sacrifice. - Statistics:
- Fisher’s exact test: comparison of treated versus control females for the fertility index.
Mann-Whitney U test: comparison of treated versus control for the number of corpora lutea, number of implantations, pre- or postimplantation losses, number of litters with early or late resorptions, and number of viable fetuses.
(Significance at the 0.05 probability level.) - Reproductive indices:
- Fertility index (number of matings (of 24) which resulted in pregancy), post implantation loss (number of implantations minus the number of viable fetuses)
- Offspring viability indices:
- Lactation index (number of pups alive at day 21 divided by the number retained at day 0)
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- yes one male rat from each treatment groups showed testicular atrophy
- Other effects:
- not examined
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- effects observed, treatment-related
- Description (incidence and severity):
- the 1 and 12 ppm groups showed higher number of corpora lutea, implantations and viable fetuses than controls as result of biological variation rather than treatment; significantly lower number of females pregnant in the 12-ppm group
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 12 ppm (analytical)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: Males where treated: nody weight, mortality, fertility
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not specified
Effect levels (F1)
- Dose descriptor:
- NOEL
- Generation:
- F1
- Effect level:
- 12 ppm (analytical)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: animals were not treated; body weight, growth, gross structural anomalies, gross pathology one male pup, derived of mating with a male rat exposed to 1 ppm, exhibited a patch of curly hair, mainly on the dorsal surface
Results: F2 generation
Effect levels (F2)
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- 12 ppm (analytical)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Gross Pathology
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.